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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3310-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.",
  "description": "FDA recall Z-3310-2024 — CooperVision, Inc. is recalling BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons. (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3310-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "CooperVision, Inc."
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3310-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3310-2024: CooperVision, Inc. is recalling BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.",
      "text": "The FDA logged enforcement record Z-3310-2024: CooperVision, Inc. is voluntarily recalling BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons. — reason: Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity. Status: Ongoing — the recall is still being carried out.. Initiated 2024-08-29. Affected lots/codes: UDI-DI: N/A  Lot Numbers: RD0122830 RD0122954 RD0122963 RD0123016 RD0123055 RD0123135 RD0123147 RD0123159 RD0123160 RD0123172 RD0123187 RD0123193 RD0123197 RD0123206 RD0123212 RD0123250 RD0123254 RD0123261 RD0123265 RD0123268 RD0123284 RD0123294 RD0123307 RD0123321 RD0123323 RD0123327 RD0123346 RD0123347 RD0123379 RD0123382 RD0123404 RD0123405 RD0123408 RD0123419 RD0123428 RD0123433 RD0123442 RD0123488 RD0123492 RD0123499 RD0123507 RD0123535 RD0123551 RD0123587 RD0123595 RD0123610 RD0123615 RD0123619 RD0123628 RD0123646 RD0123657 RD0123667 RD0123675 RD0123698 RD0123701 RD0123705 RD0123728 RD0123730 RD0123734 RD0123751 RD0123818 RD0123827 RD0123857 RD0123863 RD0123897 RD0123915 RD0123945 RD0123960 RD0123970 RD0124002 RD0124026 RD0124043 RD0124060 RD0124099 RD0124137 RD0124209 RD0124210 RD0124215 RD0124225 RD0124241 RE0071577 RE0071578 RE0071598 RE0071606 RE0071607 RE0071613 RE0071615 RE0071616 RE0071617 RE0071619 RE0071620 RE0071622 RE0071623 RE0071624 RE0071627 RE0071629 RE0071636 RE0071641 RE0071656 RE0071758 RE0071807 RE0071821 RE0071827 RE0071830 RE0071836 RE0071840 RE0071853 RE0071858 RE0071863 RE0071864 RE0071869 RE0071873 RE0071879 RE0071881 RE0071883 RE0071889 RE0071892 RE0071897 RE0071905 RE0071906 RE0071923 RE0071926 RE0071942 RE0071943 RE0071947 RE0071953 RE0071995 RE0071996 RE0072056 RE0072271 RE0072283 RE0072297 RE0072481 RE0072502. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
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      "grounding": {
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        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3310-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3310-2024&lang=eng"
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      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3310-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3310-2024 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3310-2024&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3310-2024&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3310-2024/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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      "name": "FDA recall details — Z-3310-2024",
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            "Field": "Recall number",
            "Value": "Z-3310-2024",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "CooperVision, Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-08-29",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "UDI-DI: N/A  Lot Numbers: RD0122830 RD0122954 RD0122963 RD0123016 RD0123055 RD0123135 RD0123147 RD0123159 RD0123160 RD0123172 RD0123187 RD0123193 RD0123197 RD0123206 RD0123212 RD0123250 RD0123254 RD0123261 RD0123265 RD0123268 RD0123284 RD0123294 RD0123307 RD0123321 RD0123323 RD0123327 RD0123346 RD0123347 RD0123379 RD0123382 RD0123404 RD0123405 RD0123408 RD0123419 RD0123428 RD0123433 RD0123442 RD0123488 RD0123492 RD0123499 RD0123507 RD0123535 RD0123551 RD0123587 RD0123595 RD0123610 RD0123615 RD0123619 RD0123628 RD0123646 RD0123657 RD0123667 RD0123675 RD0123698 RD0123701 RD0123705 RD0123728 RD0123730 RD0123734 RD0123751 RD0123818 RD0123827 RD0123857 RD0123863 RD0123897 RD0123915 RD0123945 RD0123960 RD0123970 RD0124002 RD0124026 RD0124043 RD0124060 RD0124099 RD0124137 RD0124209 RD0124210 RD0124215 RD0124225 RD0124241 RE0071577 RE0071578 RE0071598 RE0071606 RE0071607 RE0071613 RE0071615 RE0071616 RE0071617 RE0071619 RE0071620 RE0071622 RE0071623 RE0071624 RE0071627 RE0071629 RE0071636 RE0071641 RE0071656 RE0071758 RE0071807 RE0071821 RE0071827 RE0071830 RE0071836 RE0071840 RE0071853 RE0071858 RE0071863 RE0071864 RE0071869 RE0071873 RE0071879 RE0071881 RE0071883 RE0071889 RE0071892 RE0071897 RE0071905 RE0071906 RE0071923 RE0071926 RE0071942 RE0071943 RE0071947 RE0071953 RE0071995 RE0071996 RE0072056 RE0072271 RE0072283 RE0072297 RE0072481 RE0072502",
            "Status": "recorded"
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the country of Canada.",
            "Status": "recorded"
          }
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      ]
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}